Paclitaxel Plus Cetuximab as Induction Chemotherapy for Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma Unfit for Cisplatin-Based Chemotherapy.

Induction chemotherapy (ICT) followed by definitive treatment is an accepted non-surgical approach for locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). However, ICT remains a challenge for cisplatin-unfit patients. We evaluated paclitaxel and cetuximab (P-C) as ICT in a cohort of LA-HNSCC patients unfit for cisplatin. This is a retrospective analysis of patients with newly diagnosed LA-HNSCC considered unfit for cisplatin-based chemotherapy (age >70 and/or ECOG≥2 and/or comorbidities) treated with weekly P-C followed by definitive radiotherapy and cetuximab (RT-C) between 2010 and 2017. Toxicity and objective response rate (ORR) to ICT and RT-C were collected. Median overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method. Cox regression analysis was performed to determine baseline predictors of OS and PFS. A total of 57 patients were included. Grade 3-4 toxicity rate to ICT was 54.4%, and there was a death deemed treatment-related (G5). P-C achieved an ORR of 66.7%, including 12.3% of complete responses (CR). After P-C, 45 patients (78.9%) continued with concomitant RT-C. Twenty-six patients (45.6%) achieved a CR after definitive treatment. With a median follow-up of 21.7 months (range 1.2-94.6), median OS and PFS were 22.9 months and 10.7 months, respectively. The estimated 2-year OS and PFS rates were 48.9% and 33.7%, respectively. Disease stage had a negative impact on OS (stage IVb vs. III-IVa: HR = 2.55 [1.08-6.04], P-C was a well-tolerated and active ICT regimen in this cohort of LA-HNSCC patients unfit for cisplatin-based chemotherapy. P-C might represent a valid ICT option for unfit patients and may aid patient selection for definitive treatment.

Copyright © 2022 Marín-Jiménez, Oliva, Peinado Martín, Cabezas-Camarero, Plana Serrahima, Vázquez Masedo, Lozano Borbalas, Cabrera Martín, Esteve, Iglesias Moreno, Vilajosana Altamis, Arribas Hortigüela, Taberna Sanz, Pérez-Segura and Mesía.

OM: Advisory Role: Merck and Bristol Myers Squibb. Financial Interests, Personal, Other, Travel/Accommodation expenses: MSD Oncology, Merck, Bristol Myers Squibb, and Transgene. Personal and/or Institutional Research Grant: GlaxoSmithKline and Roche. Financial Interests, Personal, and/or Institutional Research Grant: Bristol-Myers Squibb, Merck, MSD Oncology, Isa Therapeutics, AXL Oncology, Boehringer Ingelheim, Roche, Debiopharm, Abbvie, and Ayala Therapeutics. C-CS reports advisory role for Merck KGaA and Bristol-Myers Squibb; grant/research support (clinical trials) from AstraZeneca, Merck Sharp & Dohme, Pfizer, and Merck KGaA; travel and academic expenses from Merck KGaA, Bristol-Myers Squibb, and Merck Sharp & Dohme. PM reports consultant role for Nanobiotix and travel non-financial support and academic work fees from Merck, Eisai, and Bristol-Myers Squibb. TM reports consultant role for MSD, Merck, and Nanobiotics; speaker’s bureau for Bristol-Myers Squibb, MSD, AstraZeneca, and Merck; and travel and academic work fees from Merck and MSD. MR reports consultant role for BMS, MSD, Merck, Astra Zeneca, Nanobiotics, Roche, and Bayer; speaker’s bureau for BMS, MSD, Roche, and Merck; and travel and academic work fees from Roche, BMS, and Merck. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.